EP2300098B1 - Device for carrying out an eye treatment for prevention of presbyopia and glaucoma - Google Patents

Device for carrying out an eye treatment for prevention of presbyopia and glaucoma Download PDF

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Publication number
EP2300098B1
EP2300098B1 EP09762195.7A EP09762195A EP2300098B1 EP 2300098 B1 EP2300098 B1 EP 2300098B1 EP 09762195 A EP09762195 A EP 09762195A EP 2300098 B1 EP2300098 B1 EP 2300098B1
Authority
EP
European Patent Office
Prior art keywords
electrodes
stimulation
per
ciliary
muscle
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Active
Application number
EP09762195.7A
Other languages
German (de)
English (en)
French (fr)
Other versions
EP2300098A2 (en
Inventor
Massimo Filippello
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Sooft Italia SpA
Original Assignee
Sooft Italia SpA
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Filing date
Publication date
Application filed by Sooft Italia SpA filed Critical Sooft Italia SpA
Publication of EP2300098A2 publication Critical patent/EP2300098A2/en
Application granted granted Critical
Publication of EP2300098B1 publication Critical patent/EP2300098B1/en
Active legal-status Critical Current
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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F9/00—Methods or devices for treatment of the eyes; Devices for putting-in contact lenses; Devices to correct squinting; Apparatus to guide the blind; Protective devices for the eyes, carried on the body or in the hand
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00—Electrotherapy; Circuits therefor
    • A61N1/18—Applying electric currents by contact electrodes
    • A61N1/32—Applying electric currents by contact electrodes alternating or intermittent currents
    • A61N1/36—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
    • A61N1/36046—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation of the eye
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00—Electrotherapy; Circuits therefor
    • A61N1/02—Details
    • A61N1/04—Electrodes
    • A61N1/0404—Electrodes for external use
    • A61N1/0408—Use-related aspects
    • A61N1/0452—Specially adapted for transcutaneous muscle stimulation [TMS]
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00—Electrotherapy; Circuits therefor
    • A61N1/02—Details
    • A61N1/04—Electrodes
    • A61N1/0404—Electrodes for external use
    • A61N1/0408—Use-related aspects
    • A61N1/0456—Specially adapted for transcutaneous electrical nerve stimulation [TENS]
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00—Electrotherapy; Circuits therefor
    • A61N1/02—Details
    • A61N1/04—Electrodes
    • A61N1/0404—Electrodes for external use
    • A61N1/0472—Structure-related aspects
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00—Electrotherapy; Circuits therefor
    • A61N1/02—Details
    • A61N1/04—Electrodes
    • A61N1/05—Electrodes for implantation or insertion into the body, e.g. heart electrode

Definitions

  • the short side of the ciliary body 19 is responsible for the secretion of the aqueous humour. Contained within the ciliary body 19 is the ciliary muscle. The muscle is in direct contact with the ocular structure responsible for outflow of the aqueous humour (sclero-corneal trabeculate).
  • the ciliary processes When the ciliary muscle is relaxed, the ciliary processes keep contracted the suspensory ligaments of the Zinn's zonule, which, in turn, pull on the capsule of the crystalline at the equatorial height, and this causes a reduction of the curvature of the faces of the crystalline, which thus becomes less convex, enabling vision of distant objects.
  • ageing determines a progressive reduction of the power of accommodation.
  • the graph highlights that at the age of approximately thirteen the amplitude is 13 diopters, whereas over sixty it drops to less than 1 diopter.
  • the glaucomatous desease has numerous causes that lead to different types of glaucoma.
  • the aqueous humour is a liquid that fills the anterior and posterior chambers of the eye. It is produced by an anatomical structure called ciliary body, which in general does not undergo any reduction in efficiency over time. Instead, the system of drainage represents the role for which an anatomical structure called sclero-corneal trabeculate is responsible. This is formed by a dense mesh of fibres, which between them constitute a reticulum, which in turn filters the aqueous humour towards the ocular lymphatic and venous systems.
  • trabecular meshes are kept efficient through the contraction of the ciliary muscle, which, being connected via a tendinous connection to the trabeculate, keeps it efficient thanks to the action of continuous stretching of the trabecular meshes.
  • the latter are to be envisioned as an infinite series of microholes, which, only if they are kept pervious, are able to allow easy passage the aqueous humour.
  • the US patent 5,782,894 relates a device and method that satisfies the need of restoring the loss of near vision resulting from presbyopia without the use of eyeglasses.
  • the device and the method focus the eyes upon a near object by electrically stimulating the ciliary muscles when the eyes converge to view the near object.
  • the ciliary muscles are stimulated proportionally to the contraction of the internal rectus muscles to ensure that the eyes focus to the specific distance of the near object.
  • a sensor is surgically installed on the internal rectus muscle of each eye;
  • a stimulator is surgically installed on the ciliary muscle of each eye; and
  • a control unit which communicates between the sensors and stimulators is surgically installed under the skin.
  • the described stimulations allow the lens of the eye to widen and focus on near objects and thereby prevent or treat presbyopia.
  • the US patent 6, 083, 251 discloses a treatment apparatus including a low-frequency signal generator for generating low-frequency signals of 20 Hz which have a gradually increasing amplitude and are effective to stimulate the ciliary muscle as well.
  • compensated biphasic square-wave pulses wherein the width of each pulse is between 1-15 ms and the intensity of current is in a range of 0,5-10 ⁇ A
  • means for stimulating of the ciliary body comprising four electrodes positioned on a lens that can be positioned in direct contact with the area of the cyliary muscle during stimulation.
  • the inventor has found that stimulation of the ciliary body using two or more electrodes with appropriate current pulse trains determines contraction of the muscle.
  • This contraction if applied in a rhythmic way at a constant frequency, is able to subject the ciliary muscle to a passive gymnastics, increasing the force of contraction and dimensions and efficiency of the muscle. This increase of force enables the crystalline to move with a greater efficiency and consequently increase its power of accommodation.
  • the contraction of the ciliarymuscle stretches the tendinous formation in direct contact with the sclero-corneal trabeculate and enables, through stretching thereof, an increase in the distance between the lamellae of the sclero-corneal angle.
  • the action of stretching on the trabecular meshes favours de-obstruction thereof and facilitates the outflow of the aqueous humour.
  • Stimulation of the anatomical area corresponding to the ciliary body occurs through the use of conductive electrodes positioned in direct contact with the bulbar conjunctiva at a distance of 2 to 5 mm from the corneal limbus.
  • the corneal limbus is the area of passage between the cornea and the sclera.
  • the electrodes must be in direct contact with the area of the ciliary muscle for the entire time of stimulation.
  • FIG. 3 is a profile view of a contact lens 20 containing four electrodes 22, from which there exits the electrical wire 24 that connects up to the electrostimulator (not illustrated).
  • the total diameter of the lens ranges from 16 to 20 mm (basic radius from 7.0 to 9.5 mm).
  • the electrodes are positioned at an equal distance apart.
  • the distance between each electrode and the centre of the contact lens ranges from 8 to 11 mm.
  • the distance between the electrode and the outer rim of the lens ranges from 1 to 4 mm.
  • the electrodes must have an ample contact on the conjunctiva: their ideal shape must consequently be like the one illustrated in Figure 4 , i.e., arched, or alternatively rectangular with chamfered edges or else simply spherical.
  • the minimum dimensions are 2 mm in width and 1 mm in height for the non-spherical shapes and 2 mm for the spherical shape.
  • stimulation of the ciliary structure is to be carried out in different ways and with different times in order to be able to differentiate the effects.
  • the effect of stimulation of the ciliary body with d.c. microcurrents is dose- and time-dependent.

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  • Health & Medical Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Public Health (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Radiology & Medical Imaging (AREA)
  • Ophthalmology & Optometry (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Vascular Medicine (AREA)
  • Electrotherapy Devices (AREA)
  • Rehabilitation Tools (AREA)
  • Prostheses (AREA)
EP09762195.7A 2008-06-12 2009-06-11 Device for carrying out an eye treatment for prevention of presbyopia and glaucoma Active EP2300098B1 (en)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
IT000309A ITRM20080309A1 (it) 2008-06-12 2008-06-12 Metodo di trattamento oculare per la prevenzione della presbiopia e del glaucoma e mezzi per effettuare tale trattamento
PCT/IT2009/000255 WO2009150688A2 (en) 2008-06-12 2009-06-11 Method of eye treatment for prevention of presbyopia and glaucoma, and means for carrying out said treatment

Publications (2)

Publication Number Publication Date
EP2300098A2 EP2300098A2 (en) 2011-03-30
EP2300098B1 true EP2300098B1 (en) 2016-04-20

Family

ID=40302053

Family Applications (1)

Application Number Title Priority Date Filing Date
EP09762195.7A Active EP2300098B1 (en) 2008-06-12 2009-06-11 Device for carrying out an eye treatment for prevention of presbyopia and glaucoma

Country Status (14)

Country Link
US (1) US9014812B2 (ko)
EP (1) EP2300098B1 (ko)
JP (1) JP2011522662A (ko)
KR (1) KR101675169B1 (ko)
CN (1) CN102099079B (ko)
AU (1) AU2009258863B2 (ko)
BR (1) BRPI0909984A2 (ko)
CA (1) CA2727479A1 (ko)
EA (1) EA021305B1 (ko)
ES (1) ES2573332T3 (ko)
IL (1) IL209948A (ko)
IT (1) ITRM20080309A1 (ko)
MX (1) MX2010013623A (ko)
WO (1) WO2009150688A2 (ko)

Families Citing this family (19)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
ITTP20090002A1 (it) * 2009-11-25 2011-05-26 O V I Optical Venture Itali Srl Dispositivo da applicare sulla superficie dell'occhio per trattamento di elettrostimolazione
US9821159B2 (en) 2010-11-16 2017-11-21 The Board Of Trustees Of The Leland Stanford Junior University Stimulation devices and methods
AU2011328900B2 (en) 2010-11-16 2015-03-19 The Board Of Trustees Of The Leland Stanford Junior University Systems and methods for treatment of dry eye
CN102178998B (zh) * 2011-04-29 2013-05-01 上海交通大学 面向面瘫康复的角膜接触镜式柔性微电极
EP2967817B1 (en) 2013-03-12 2021-03-10 Oculeve, Inc. Implant delivery devices and systems
CA2883874A1 (en) 2013-04-19 2014-10-23 Oculeve, Inc. Nasal stimulation devices and methods
US20140371565A1 (en) * 2013-06-14 2014-12-18 University Of Houston System Accommodation stimulation and recording device
US10493274B2 (en) 2013-12-09 2019-12-03 Purdue Research Foundation Optical pressure treatment through electrical stimulation
CN111298285A (zh) 2014-02-25 2020-06-19 奥库利维公司 用于鼻泪刺激的聚合物制剂
AU2015292278B2 (en) 2014-07-25 2020-04-09 Oculeve, Inc. Stimulation patterns for treating dry eye
US9764150B2 (en) * 2014-10-22 2017-09-19 Oculeve, Inc. Contact lens for increasing tear production
CN107106843A (zh) 2014-10-22 2017-08-29 奥库利维公司 用于治疗干眼症的刺激装置和方法
US10426958B2 (en) 2015-12-04 2019-10-01 Oculeve, Inc. Intranasal stimulation for enhanced release of ocular mucins and other tear proteins
US10252048B2 (en) 2016-02-19 2019-04-09 Oculeve, Inc. Nasal stimulation for rhinitis, nasal congestion, and ocular allergies
EP3452166A4 (en) 2016-05-02 2019-12-18 Oculeve, Inc. INTRANASAL STIMULATION FOR THE TREATMENT OF DISEASES OF MEIBOM'S GLANDS AND BLEPHARITIS
WO2017223387A1 (en) 2016-06-22 2017-12-28 Pedro Irazoqui Wireless glaucoma therapy
EP3547898A4 (en) 2016-12-02 2020-07-08 Oculeve, Inc. APPARATUS AND METHOD FOR PREDICTING EYE DROUGHT AND TREATMENT RECOMMENDATION
EP4360700A3 (en) 2017-08-04 2024-06-05 Purdue Research Foundation Multi-coil wireless power transfer assembly for wireless glaucoma therapy
US11191962B2 (en) 2018-03-12 2021-12-07 Purdue Research Foundation Stimulus coil and pulse generator for wireless glaucoma therapy

Citations (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20070027502A1 (en) * 2005-07-29 2007-02-01 Nidek Co., Ltd. Visual restoration aiding device

Family Cites Families (10)

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Publication number Priority date Publication date Assignee Title
US4271841A (en) 1980-01-31 1981-06-09 Medtronic, Inc. Electro-ocular stimulation system
US4603697A (en) * 1985-01-07 1986-08-05 William Kamerling System for preventing or treating open angle glaucoma and presbyopia
US6120460A (en) * 1996-09-04 2000-09-19 Abreu; Marcio Marc Method and apparatus for signal acquisition, processing and transmission for evaluation of bodily functions
US5782894A (en) * 1997-03-05 1998-07-21 Israel; Ben Device and method for improving ocular focusing at near vision points
JPH1157030A (ja) * 1997-08-27 1999-03-02 Kohei Shindo 治療器
US6083251A (en) * 1997-11-13 2000-07-04 Shindo; Kohei Eye treatment method and apparatus
JP2003210513A (ja) * 2002-01-23 2003-07-29 Nidek Co Ltd 眼科用治療装置
US7321795B2 (en) * 2003-03-24 2008-01-22 Les Bogdanowicz Compositions for electric stimulation of the eye
EP1876987A4 (en) * 2005-04-26 2009-11-18 Biolase Tech Inc METHODS OF TREATING EYE DISEASES
CN2892143Y (zh) * 2005-08-08 2007-04-25 新视界有限公司 雷多频远视老视及青光眼多功能治疗仪

Patent Citations (1)

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Publication number Priority date Publication date Assignee Title
US20070027502A1 (en) * 2005-07-29 2007-02-01 Nidek Co., Ltd. Visual restoration aiding device

Also Published As

Publication number Publication date
IL209948A (en) 2017-05-29
WO2009150688A2 (en) 2009-12-17
EA021305B1 (ru) 2015-05-29
ITRM20080309A1 (it) 2009-12-13
JP2011522662A (ja) 2011-08-04
EA201001839A1 (ru) 2011-08-30
ES2573332T3 (es) 2016-06-07
BRPI0909984A2 (pt) 2015-10-20
WO2009150688A3 (en) 2010-05-06
IL209948A0 (en) 2011-02-28
MX2010013623A (es) 2011-09-28
CA2727479A1 (en) 2009-12-17
CN102099079B (zh) 2016-04-06
EP2300098A2 (en) 2011-03-30
AU2009258863B2 (en) 2015-06-25
KR101675169B1 (ko) 2016-11-10
CN102099079A (zh) 2011-06-15
US9014812B2 (en) 2015-04-21
AU2009258863A1 (en) 2009-12-17
US20110082518A1 (en) 2011-04-07
KR20110025691A (ko) 2011-03-10

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